Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding

NCT ID: NCT02853552

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 4330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

Brief Summary

The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.

Detailed Description

This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:

Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.

Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.

During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

Misoprostol

800mcg misoprostol taken sublingually

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant women living in sample districts

Exclusion Criteria

• Unable to provide informed consent

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Committee for Maternal & Neonatal Health

UNKNOWN

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dina Abbas, MPH

Role: CONTACT

212-448-1230

Other Identifiers

3007

Identifier Type: -

Identifier Source: org_study_id